Bath And Body Works Spf 35 Lip Balm

Bath And Body Works Spf 35 Lip Balm
SPL v1
SPL
SPL Set ID 0f8b024c-c481-951b-e063-6394a90ac63c
Route
TOPICAL
Published
Effective Date 2024-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octisalate (5 g) Avobenzone (2.5 g)
Inactive Ingredients
Yellow Wax Sunflower Oil Hydrogenated Coco-glycerides Lauroyl Lysine Benzyl Alcohol Castor Oil Butyloctyl Salicylate Mica Soybean Oil Candelilla Wax Shea Butter Cocoa Butter Garcinia Indica Seed Butter Meadowfoam Seed Oil .alpha.-tocopherol, Dl- Benzyl Salicylate Carnauba Wax Benzyl Benzoate Stevia Rebaudiuna Leaf Anise Oil Coconut Oil Titanium Dioxide Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow Fd&c Yellow No. 5 Aluminum Lake D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-22
Description

Avobenzone 2.5% Homosalate 10% Octisalate 5%

Medication Information

Warnings and Precautions

For external use only

Do not use on domaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Sop use and ask a doctor if rash occurs

Indications and Usage

Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply:

  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours
Description

Avobenzone 2.5% Homosalate 10% Octisalate 5%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Section 51945-4

Section 53413-1

1-800-395-1001

Section 55105-1

Avobenzone - Sunscreen

Homosalate - Sunscreen

Octisalate - Sunscreen

Section 55106-9

Avobenzone 2.5%

Homosalate 10%

Octisalate 5%

Section 59845-8

Protect the product in this container from excessive heat and direct sun

Section 60561-8

Limit time in the sun, especially from 10am - 2pm

Wear long sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: ask a doctor

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply:

  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every 2 hours
Warnings and Precautions (34071-1)

For external use only

Do not use on domaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Sop use and ask a doctor if rash occurs

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-395-1001

Section 55105-1 (55105-1)

Avobenzone - Sunscreen

Homosalate - Sunscreen

Octisalate - Sunscreen

Section 55106-9 (55106-9)

Avobenzone 2.5%

Homosalate 10%

Octisalate 5%

Section 59845-8 (59845-8)

Protect the product in this container from excessive heat and direct sun

Section 60561-8 (60561-8)

Limit time in the sun, especially from 10am - 2pm

Wear long sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: ask a doctor

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.505619 · Updated: 2026-03-14T23:02:25.522673